CenterWatch

1+ months

Biosample Operations Manager

Kelly Services
South San Francisco, CA 94080
**Biosample Operations Manager (BOM)**





**Job Purpose:**



The Biosample Operations Manager (BOM) plans and coordinates all operational activities required for the collection, delivery and assay of Biomarker Samples (Dx and PD) within a clinical study. The BOM works closely with Scientists to execute exploratory and Companion Diagnostic biomarker strategy. The BOM serves as a single point of contact on Protocol Execution Teams, Biomarker Subteams and with CRO partners on all aspects of Biosample operations.





**Primary Responsibilities and Accountabilities:**



Operations support for Biomarker Scientists




+ Provide input on Protocol/ICF development and IRB/HA/EC questions in alignment with study protocols

+ Facilitate Central Lab set up, including sample collection and processing instructions, kit contents, shipping conditions and logistics

+ Oversee outsourcing to CROs and vendor management (specialty lab vendors for biomarker assays)

+ Manage timelines for sample testing and data transfer with both internal testing labs and external vendors





Single point of contact for status of clinical trial samples and biomarker data




+ Manage sample transfer/discrepancy resolution with Central Lab, Sample Handling and testing group/vendor

+ Provide sample and assay status updates (high level metrics provided to Biomarker subteams)





Execution of Biomarker and CDx strategy




+ Develop Biomarker Plan with the Biomarker Subteam Leader (outline execution of exploratory and CDx biomarker strategy and testing timelines)

+ Lead Biomarker Execution Working Group (review study updates, timelines/milestones, align on Biomarker Plan and deliverables)









**Requirements**



Life sciences degree and a minimum of 4 years working experience in the healthcare industry





Proven clinical development experience working in teams running clinical studies, monitoring clinical studies or experience of working in clinical studies at an investigator site





Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples



Proven critical reasoning skills including the identification and resolution of complex problems



Detail oriented with the ability to work independently and manage multiple competing priorities



Excellent verbal, written and presentation skills



Proven ability to work successfully under pressure



Ability to work in a multifunctional team environment, interact with a wide variety of internal and external customers and relate effectively to people at all levels of the organization








**Why Kelly** **** **?**



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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Posted: 2019-09-09 Expires: 2019-12-09

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Biosample Operations Manager

Kelly Services
South San Francisco, CA 94080

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